distributed to both national and international investigators. In addition, remnant body fluids are available on some patients and limited histological services can be obtained by special arrangement. Requests for large sample sizes, large numbers of biospecimens, rare biospecimens or biospecimens in high demand may be served if they do not negatively impact the availability of biospecimens for other researchers. Investigators must complete a standard CHTN application which includes a brief description of their research project, funding information, and biospecimen requirements. In addition, researchers must submit documentation of his/her Institutional Review Board (IRB) approval or exemption. The intent of the CHTN is to encourage research using human biospecimens for the good of the public rather than for private gain. The CHTN Agreement for Use of Tissue, which must be signed by all CHTN investigators, states “The recipient agrees that it shall not sell any portion of the tissues provided by the CHTN, or products directly extracted from these tissues (e.g. protein, mRNA or DNA). The recipient agrees that it shall not transfer tissue (or any portion thereof) supplied by the CHTN to third parties without the prior written permission of the CHTN.” Policies and procedures for the protection of human subjects The CHTN has established operating policies and procedures that protect the subjects from whom CHTN biospecimens are obtained. These policies and procedures are consistent with current regulations and guidance for repositories from the Office of Human Research Protections (OHRP) in the Department of Human and Health Services (DHHS). The following policies and procedures govern collection of biospecimens and their distribution to researchers: CHTN biospecimens are derived from material that is removed as part of routine medical care or collected as autopsy biospecimens; all biospecimens are collected in accordance with state and local laws. Only residual material not needed for patient care is distributed for research. Every CHTN institution has obtained a human subjects Assurance from the OHRP of the DHHS. The Assurance documents are an agreement stating that the institution will comply with Federal human subject’s regulations (The "Common Rule;" 45CFR46). Each division of the CHTN has received approval for collection and distribution of specimens from its local Institutional Review Board (IRB). The IRBs review the procedures in place to ensure adequate protection of human subjects and protection of patient privacy and confidentiality. The approvals are reviewed by the IRB every year. Donor identities or other identifying information is never